ISO 9001 2015 Manufacturing Supplier Audit Checklist eAuditor Audits & Inspections

https://eauditor.app/2024/05/13/iso-90012015-manufacturing-supplier-audit/
ISO 9001:2015 Manufacturing Supplier Audit Checklist
Creating a comprehensive ISO 9001:2015 manufacturing supplier audit checklist involves several key components. Below is a general outline you can customize according to your specific needs and requirements:
ISO 9001-2015 Manufacturing Supplier Audit
General Information:
Supplier Name:
Supplier Location:
Date of Audit:
Auditor Name(s):
Audit Scope:
Documentation Review:
Quality Manual:
Procedures and Work Instructions:
Records of Training and Competence:
Document Control Procedures:
Quality Policy and Objectives:
Corrective and Preventive Action Records:
Control of Non-Conforming Products:
Internal Audit Reports:
Management System:
Organizational Structure and Responsibilities:
Management Commitment to Quality:
Risk Management Processes:
Quality Planning and Objectives:
Customer Focus and Satisfaction:
Continual Improvement Processes:
Change Management Procedures:
Resource Management:
Competence, Awareness, and Training:
Infrastructure and Work Environment:
Availability of Resources:
Personnel Facilities and Welfare:
Equipment Maintenance and Calibration:
Product Realization:
Planning of Product Realization:
Customer Requirements Review:
Design and Development Processes (if applicable):
Purchasing Process and Supplier Evaluation:
Control of Production and Service Provision:
Validation of Processes for Production:
Identification and Traceability of Products:
Customer Property Protection:
Measurement, Analysis, and Improvement:
Monitoring and Measurement of Processes:
Product Conformity and Acceptance Criteria:
Control of Monitoring and Measuring Equipment:
Analysis of Data for Performance:
Internal Audit Process and Results:
Corrective and Preventive Action Processes:
Management Review Meeting Records:
Observations and Recommendations:
Compliance with ISO 9001:2015 Requirements:
Strengths of the Supplier’s Quality Management System:
Areas for Improvement or Corrective Action:
Recommendations for Enhancing Performance:
Conclusion:
Overall Assessment of Supplier’s Compliance:
Identified Risks and Opportunities:
Summary of Audit Findings:
Follow-up Actions and Timelines:

1. ISO
9001:2015MANUFACTURING
SUPPLIER AUDIT

2. Creating a comprehensive ISO 9001:2015 manufacturing
supplier audit checklist involves several key components
General
Information
Supplier Name Supplier Location Date of Audit Auditor Name
Audit Scope
Documentation
Review
Quality Manual
Procedures and
Work Instructions

3. Documentation
Review
Records of Training and Competence
Document Control Procedures
Quality Policy and Objectives
Corrective and Preventive Action Records
Control of Non-Conforming Products
Internal Audit Reports
Management System
Organizational Structure and Responsibilities
Management Commitment to Quality
Risk Management Processes

4. Management
System
Quality Planning and Objectives
Customer Focus and Satisfaction
Continual Improvement Processes
Change Management Procedures
Resource Management
Competence, Awareness, and Training
Infrastructure and Work Environment
Availability of Resources
Personnel Facilities and Welfare
Equipment Maintenance and Calibration

5. Product Realization
◦Planning of Product Realization
◦Customer Requirements Review
◦Design and Development Processes
◦Purchasing Process and Supplier Evaluation
◦Control of Production and Service Provision
◦Validation of Processes for Production
◦Identification and Traceability of Products
◦Customer Property Protection
◦Measurement, Analysis, and Improvement

6. Measurement, Analysis, and Improvement
Monitoring and
Measurement of
Processes
Product Conformity
and Acceptance
Criteria
Control of Monitoring
and Measuring
Equipment
Analysis of Data for
Performance
Internal Audit Process
and Results
Corrective and
Preventive Action
Processes
Management Review
Meeting Records
Observations and
Recommendations
Compliance with ISO
9001:2015
Requirements
Strengths of the
Supplier’s Quality
Management System

7. Conclusion
◦Areas for Improvement or Corrective Action
◦Recommendations for Enhancing Performance
◦Conclusion
◦Overall Assessment of Supplier’s Compliance
◦Identified Risks and Opportunities
◦Summary of Audit Findings
◦Follow-up Actions and Timelines
◦Ensure that each item in the ISO 9001:2015 Manufacturing Supplier
Audit Checklist is clear, measurable, and specific
◦Performing an ISO 9001:2015 supplier audit using eAuditor Audits
& Inspectionschecklist can streamline the process and improve
efficiency.

8. ISO 9001:2015 supplier audit
with eAuditor Audits &
Inspections checklist
◦Choose eAuditor Audits & Inspectionsthat allows customization of checklists or
develop your own app tailored to ISO 9001:2015 requirements
fromAndroidorAppleapp store
◦Pre-Audit Preparation
◦Input basic audit information such as supplier name, location, and audit date into
theeAuditor Audits & Inspections
◦Verify that theeAuditor Audits & Inspectionsis updated with the latest checklist
version and any specific requirements for the supplier being audited
◦Conducting the Audit
◦Start the audit process using theeAuditor Audits & InspectionsISO 9001:2015
manufacturing supplier audit checklist
◦Go through each section of the checklist systematically, recording observations,
evidence, and comments directly in the app

9. Inspection steps -eAuditor Audits
& Inspections
◦Utilize theeAuditor Audits & Inspections‘s features such as attaching photos or videos as
evidence during the audit
◦Rate each checklist item according to compliance level or severity of non-conformity
◦Document Review
◦Use the app to review documentation such as quality manuals, procedures, and records
◦Record findings and evidence directly in theeAuditor Audits & Inspectionschecklist
◦On-site Inspection
◦Use theeAuditor Audits & Inspectionsto conduct on-site inspections of facilities,
equipment, and processes
◦Capture photos or videos of any non-conformities or areas of concern
◦Communication and Collaboration
◦Assign corrective actions directly within the app and track their status

10. eAuditor Audits & Inspections Reporting
Generate Audit Report
Once the audit is complete, generate an audit report directly from the eAuditor Audits & Inspections
The report includes a summary of findings, areas of non-conformity, recommendations, and any follow-up actions required
Follow-up and Monitoring
Use eAuditor Audits & Inspectionsto track and monitor corrective actions and follow-up audits
Schedule reminders for follow-up activities and deadlines
Continuous Improvement
Use insights gathered from audits to continuously improve the audit process and the supplier’s quality management system

11. ImproveAudits
efficiency, accuracy, and
effectiveness
◦By utilizing eAuditor Audits & Inspectionschecklist for
ISO 9001:2015 audits, you can improve the efficiency,
accuracy, and effectiveness of the audit process while
ensuring compliance with quality standards